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Enhancing Donated After Cardiac Death (DCD) Utilization With Thrombolytic Therapy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by The Cleveland Clinic.
Recruitment status was:  Recruiting
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
The Cleveland Clinic Identifier:
First received: September 8, 2010
Last updated: February 12, 2014
Last verified: February 2013
The waiting list for kidney and liver transplantation continues to increase in the United States, and therefore the need grows for additional donor organs. Utilization of organs donated after cardiac death (DCD) could be one way to increase organ availability, however there are risks associated with poorer clinical outcomes, including delayed graft function and in livers specifically, ischemic-type biliary strictures (ITBS). We hypothesize that delayed graft function and ITBS events may be related to small blood clots (microthrombi) that collect in the kidneys and liver after cardiac death. Treatment of the DCD organs with a thrombolytic agent prior to implantation may reduce post-transplant morbidity and mortality, and may ultimately result in a greater number of transplantable livers and kidneys.

Condition Intervention
Liver Transplantation
Kidney Transplantation
Drug: rTPA Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Enhancing DCD Utilization With Thrombolytic Therapy

Resource links provided by NLM:

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Delayed Kidney Graft Function [ Time Frame: 3 months ]
  • Primary Liver Graft Nonfunction [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • Liver Ischemic-Type Biliary Strictures [ Time Frame: 1 year ]
  • Decreased Kidney Graft Function [ Time Frame: 1 year ]

Estimated Enrollment: 135
Study Start Date: April 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard DCD liver or kidney transplant
Standard method of liver or kidney transplant utilizing a DCD organ
Active Comparator: rTPA Treatment
Ex-vivo treatment of liver or kidney donated after cardiac death (DCD)with rTPA
Drug: rTPA Treatment
Ex-vivo treatment of DCD liver or kidney with rTPA (recombinant tissue plasminogen activator)prior to implantation
Other Name: Alteplase


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults aged 18 years and older
  • Subjects willing/able to provide written consent
  • Subjects willing/able to comply with study requirements
  • Subjects who will receive a solitary organ transplant

Exclusion Criteria:

  • Subjects requiring multi-organ transplants
  • Women who are pregnant
  • Subjects with current severe systemic infection
  • Subjects with an active infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01197573

Contact: Bijan Eghtesad, MD 216-444-9898
Contact: Mary Oldenburgh, BSN 216-444-8562

United States, Ohio
University Hospitals / Case medical Center Active, not recruiting
Cleveland, Ohio, United States, 44106
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Bijan Eghtesad, MD    216-444-9898   
Principal Investigator: Bijan Eghtesad, MD         
Sub-Investigator: David Goldfarb, MD         
Sponsors and Collaborators
The Cleveland Clinic
Health Resources and Services Administration (HRSA)
Principal Investigator: Bijan Eghtesad, MD The Cleveland Clinic
  More Information

Responsible Party: The Cleveland Clinic Identifier: NCT01197573     History of Changes
Other Study ID Numbers: CCIRB: 10-365
R38OT15491 ( Other Grant/Funding Number: HRSA )
Study First Received: September 8, 2010
Last Updated: February 12, 2014

Additional relevant MeSH terms:
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on March 22, 2017